Facilitating safe discharge through predicting disease progression in moderate COVID-19: a prospective cohort study to develop and validate a clinical prediction model in resource-limited settings.
Chandna A., Mahajan R., Gautam P., Mwandigha L., Gunasekaran K., Bhusan D., Cheung ATL., Day N., Dittrich S., Dondorp A., Geevar T., Ghattamaneni SR., Hussain S., Jimenez C., Karthikeyan R., Kumar S., Kumar S., Kumar V., Kundu D., Lakshmanan A., Manesh A., Menggred C., Moorthy M., Osborn J., Richard-Greenblatt M., Sharma S., Singh VK., Singh VK., Suri J., Suzuki S., Tubprasert J., Turner P., Villanueva AMG., Waithira N., Kumar P., Varghese GM., Koshiaris C., Lubell Y., Burza S.
BACKGROUND: In locations where few people have received COVID-19 vaccines, health systems remain vulnerable to surges in SARS-CoV-2 infections. Tools to identify patients suitable for community-based management are urgently needed. METHODS: We prospectively recruited adults presenting to two hospitals in India with moderate symptoms of laboratory-confirmed COVID-19 in order to develop and validate a clinical prediction model to rule-out progression to supplemental oxygen requirement. The primary outcome was defined as any of the following: SpO2 < 94%; respiratory rate > 30 bpm; SpO2/FiO2 < 400; or death. We specified a priori that each model would contain three clinical parameters (age, sex and SpO2) and one of seven shortlisted biochemical biomarkers measurable using commercially-available rapid tests (CRP, D-dimer, IL-6, NLR, PCT, sTREM-1 or suPAR), to ensure the models would be suitable for resource-limited settings. We evaluated discrimination, calibration and clinical utility of the models in a held-out temporal external validation cohort. RESULTS: 426 participants were recruited, of whom 89 (21.0%) met the primary outcome. 257 participants comprised the development cohort and 166 comprised the validation cohort. The three models containing NLR, suPAR or IL-6 demonstrated promising discrimination (c-statistics: 0.72 to 0.74) and calibration (calibration slopes: 1.01 to 1.05) in the validation cohort, and provided greater utility than a model containing the clinical parameters alone. CONCLUSIONS: We present three clinical prediction models that could help clinicians identify patients with moderate COVID-19 suitable for community-based management. The models are readily implementable and of particular relevance for locations with limited resources.